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Inspire Feedback Oral Recording Monitor (INFORM)

Award Number: R43HL129698
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/15/2016
PERIOD OF PERFORMANCE END DATE: 05/31/2019

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Inspire Feedback Oral Recording Monitor (INFORM) - DESCRIPTION (provided by applicant): Obstructive Sleep Apnea (OSA) is a significant problem that is currently treated with CPAP, oral appliances, or surgery. The new Inspire stimulation system has been clinically tested and shown to significantly improve inspiration in a subpopulation, but success or failure and mechanisms of action are determined only after implantation. What we propose is to develop a sensor platform for oral-lingual activity recording before and during the use of a nerve/muscle stimulator, starting with the Inspire system. The new platform will allow increased analysis of the stimulation-induced pressure and estimations of force output. This platform will record oral pressure signals and respiration from a set of Inspire patients, and then use that data to develop an algorithm to predict oro- and nasopharyngeal airway opening response to Inspire stimulation. The proposed INFORM platform will also be used to monitor tongue forces, directionality, and activity through the night and how that motion correlates to apnea or flow limitation. During wakefulness we will be able to test for muscle fatigue before implantation in the patient population. We believe a commercial INFORM platform and the proposed studies can lead to a strategy for pre-implant stratification to improve selection of treatment. Furthermore, the device will allow for tuning of stimulation parameters and monitoring of tongue functions. In further applications, we envision utility as bio-feedback for target outcomes in exercise, rehabilitation, compliance and utilization data on patients that are prescribed such exercises and a force measure in patients treated with other therapy directed at apnea prevention.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2020 ( Subtotal = $0 )
2020	2016	CLEVELAND MEDICAL DEVICES INC.	4415 EUCLID AVE STE 400	CLEVELAND	OH	44103	CUYAHOGA	USA	Cardiovascular Diseases Research	000	1	11/5/2019	NEW	$0
														Subtotal = $0

Issue Date FY: 2018 ( Subtotal = $0 )
2018	2016	CLEVELAND MEDICAL DEVICES INC.	4415 EUCLID AVE STE 400	CLEVELAND	OH	44103	CUYAHOGA	USA	Cardiovascular Diseases Research	000	1	4/26/2018	NEW	$0
														Subtotal = $0

Issue Date FY: 2016 ( Subtotal = $206,663 )
2016	2016	CLEVELAND MEDICAL DEVICES, INC	4415 EUCLID AVENUE	CLEVELAND	OH	44103	CUYAHOGA	USA	Cardiovascular Diseases Research	000	1	8/12/2016	NEW	$206,663
														Subtotal = $206,663

Grand Total All Awards = $206,663

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Inspire Feedback Oral Recording Monitor (INFORM)

Award Number: R43HL129698

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 08/15/2016

PERIOD OF PERFORMANCE END DATE: 05/31/2019

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